Phase 2 Depression and Anxiety Trial, Recruiting NCT07065240 Sponsor: Seaport Therapeutics Condition: Depression and Anxiety
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Phase 2 Depression and Anxiety Trial, Recruiting

NCT07065240
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are a man or woman between 18 and 65 years old (inclusive) and are able to understand and sign a consent form.
  • You have been formally diagnosed with major depressive disorder (MDD) as your main condition; you may also have certain anxiety conditions (such as generalized anxiety, social anxiety, or panic disorder) as long as depression is considered the main focus of your care.
  • You are currently in a depressive episode that has lasted at least 4 weeks but no longer than 18 months before the screening visit.
  • If you are a woman who could become pregnant, you must agree not to become pregnant during the study or for 30 days after your last dose, must not be breastfeeding, and must use a highly effective form of contraception throughout.
  • Your body mass index (BMI) — a measure of body weight relative to height — falls between 18 and 40.
  • You are willing and able to avoid using recreational or illegal drugs during the study.

Who may not be able to join:

  • You have a history of, or currently show signs of, depression with psychotic or catatonic features (confirm with trial site).
  • You have ever had a manic, hypomanic, or mixed episode, including episodes triggered by antidepressants.
  • You have a diagnosis of bipolar disorder, including bipolar depression.
  • You have a diagnosis of schizophrenia, schizoaffective disorder, or another psychotic disorder.
  • You have obsessive-compulsive disorder (OCD).
  • You have any lasting condition affecting memory, thinking, or cognition (confirm with trial site).
  • Your current depressive episode has already involved two or more antidepressant treatments that did not work at the right dose and for the right length of time (sometimes called treatment-resistant depression).
  • You have been admitted to a psychiatric hospital during your current depressive episode.
  • You have a significant medical condition or history that could affect your ability to participate safely (confirm with trial site).
  • You have previously had a bad reaction, intolerance, or allergy to the study drug or any of its ingredients.
  • You have a history of alcohol or drug use disorder.
  • You test positive for cannabis (marijuana) at screening.
  • You are considered to have a significant risk of suicide or of harming yourself or others.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 30 June 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Seaport Therapeutics
Registry
ClinicalTrials.gov
Start date
19 June 2025
Est. completion
1 March 2027

Where this trial is recruiting

🇧🇬 Bulgaria 🇨🇿 Czechia 🇩🇪 Germany 🇭🇺 Hungary 🇵🇱 Poland 🇸🇰 Slovakia 🇺🇸 United States

Primary endpoints

Change From Baseline to Day 42 in Hamilton Depression Rating Scale-17 (HAM-D-17) Total Score

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov